Eating Disorder Prevention Program for Women With T1D
Primary Purpose
Eating Disorders, Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Body Project
Educational Control
Sponsored by
About this trial
This is an interventional prevention trial for Eating Disorders
Eligibility Criteria
Inclusion Criteria:
I)female-identifying II) aged 15-30 years old III) diagnosis of T1D for at least a 6-month duration per American Diabetes Association(ADA) criteria who are taking insulin IV) have visited their diabetes care provider in the past year V) body image concerns
Exclusion Criteria:
I) not female identifying II) not in age range III) does not have a diagnosis of T1D for at least 6 months per ADA criteria who are taking insulin IV) have not visited their diabetes care provider in the past year V) do not report some level of body dissatisfaction
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diabetes Body Project
Educational Control Group
Arm Description
Outcomes
Primary Outcome Measures
Change over time Glycemic Control
Participants will wear a continuous-glucose monitor for 14 days as well as self-report A1c levels
Change in Eating Disorder Symptoms
Participants will complete a diagnostic interview that is administered by a trained research assistant. We will be using the Eating Disorder Diagnostic Interview (EDDI). Scores are not reported on a scale. The research assistant who conducts the diagnostic interview at post-test and 3-month follow-up will be blinded to the person's condition.
Change over time in Dieting
Assessed with the 10-item Dutch Restrained Eating Scale (DRES; van Strien et al., 1986) that measures dieting behaviors over the past month. Scores for each item range from 1 = Never to 5 = Always with higher scores indicating more frequent dieting behaviors.
Change over time in Body Dissatisfaction
Assessed with the 10-item Body Dissatisfaction Scale (BDI; Berscheid et al., 2973) which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 5 = extremely satisfied. Lower scores indicate greater body dissatisfaction.
Change over time in Ideal Body Beliefs
Assessed with the 8-item Ideal-Body Stereotype Scale-Revised (Stice et al., 2017) which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater belief in the thin-deal.
Change over time in Diabetes-Specific Eating Pathology
Assessed with the 16-item Diabetes Eating Problem Survey-Revised (DEPS-R; Markowitz et al,.2010). Each item is assessed on a scale of 0 = Never to 5= Always. Higher scores indicate greater eating pathology specific to individuals with Type 1 Diabetes such as purposefully not taking enough insulin.
Change over time in Diabetes-Specific Distress
Assessed with the 28-item Type 1 Diabetes Distress Scale (DDS; Fisher et al., 2015) which measures distress related to diabetes. Each item is assessed on a scale of 1 = Not a Problem to 6 = A Very Serious Problem. High scores indicate greater distress that are related to living with Type 1 Diabetes.
Change over time in Negative Affect
Negative affect will be assessed with the sadness, guilt, and fear/anxiety subscales (totaling 20 items) from the Positive Affect and Negative Affect Scale-Revised (PANAS-X; Watson & Clark, 1992). Each item is scored on a scale of 1 = Not at All to 5 = Extremely. Higher scores indicate greater negative affect.
Change over time in Perceived Well-Being as assessed by the World Health Organization Well-Being Index (WHO-5; deWit et al., 2007).
Assessed with the 5-item World Health Organization Well-Being Index (WHO-5; deWit et al., 2007) that measures health related quality of life. Each item is scored on a scale of 0 = At no Time to 5 = All of the Time. Higher scores indicate greater well-being
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05264376
Brief Title
Eating Disorder Prevention Program for Women With T1D
Official Title
Evaluating an Eating Disorder Prevention Program for Young Women With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
April 15, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to test the effectiveness of an evidence-based eating- disorder prevention program specifically targeted for individuals with Type 1 Diabetes (T1D) compared to an educational control group. The Diabetes Body Project (DBP), is an adaptation of the Body Project which is the only eating disorder prevention program to have repeatedly produced effects when evaluated by independent researchers, produced stronger effects than credible alternative interventions, and affected objective outcomes. DBP has been adapted slightly for individuals with T1D who are at ultra-high risk for eating disorders. The study aims to test the effectiveness of the DBP of reducing body image concerns and reducing eating pathology and improving glycemic control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Type 1 Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The Diabetes Body Project and educational control are both designed to last six weeks, for one hour each week. They both focus on diabetes-specific health issues as well as generic issues with thin-idealization.
Masking
Investigator
Masking Description
The research assistant conducting the diagnostic interviews after the end of the prevention program and at 3-month follow-up won't know whether the participant was in the Diabetes Body Project or the educational control group.
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetes Body Project
Arm Type
Experimental
Arm Title
Educational Control Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Body Project
Intervention Description
The Diabetes Body Project (DBP) is an adapted version of the Body Project Prevention program designed specifically for individuals with Type 1 Diabetes. DBP consists of six weekly, one-hour long sessions. Group participants complete the exercises from the original Body Project and also new diabetes-specific content, drawn from Olmsted et al. (2002) that is delivered in a dissonance-based interactive format with Socratic questions from group leaders encourage participants to generate their own answers.
Intervention Type
Behavioral
Intervention Name(s)
Educational Control
Intervention Description
We selected a T1D management/Eating disorder psychoeducational comparison condition previously tested (Olmsted et al., 2002) to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures by Dr. Olmsted will be delivered in 6 1-hour blocks. Topics include basic information about the various EDs, complications of ED behaviors, diabetes and body image, effects of dieting on blood glucose, and the risk of complications.
Primary Outcome Measure Information:
Title
Change over time Glycemic Control
Description
Participants will wear a continuous-glucose monitor for 14 days as well as self-report A1c levels
Time Frame
Pre intervention obtained on intake and 3 months after the conclusion of the intervention.
Title
Change in Eating Disorder Symptoms
Description
Participants will complete a diagnostic interview that is administered by a trained research assistant. We will be using the Eating Disorder Diagnostic Interview (EDDI). Scores are not reported on a scale. The research assistant who conducts the diagnostic interview at post-test and 3-month follow-up will be blinded to the person's condition.
Time Frame
pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Title
Change over time in Dieting
Description
Assessed with the 10-item Dutch Restrained Eating Scale (DRES; van Strien et al., 1986) that measures dieting behaviors over the past month. Scores for each item range from 1 = Never to 5 = Always with higher scores indicating more frequent dieting behaviors.
Time Frame
pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Title
Change over time in Body Dissatisfaction
Description
Assessed with the 10-item Body Dissatisfaction Scale (BDI; Berscheid et al., 2973) which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 5 = extremely satisfied. Lower scores indicate greater body dissatisfaction.
Time Frame
pre intervention obtained on intake, immediately post intervention, and 3-months after the conclusion of the intervention
Title
Change over time in Ideal Body Beliefs
Description
Assessed with the 8-item Ideal-Body Stereotype Scale-Revised (Stice et al., 2017) which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater belief in the thin-deal.
Time Frame
pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Title
Change over time in Diabetes-Specific Eating Pathology
Description
Assessed with the 16-item Diabetes Eating Problem Survey-Revised (DEPS-R; Markowitz et al,.2010). Each item is assessed on a scale of 0 = Never to 5= Always. Higher scores indicate greater eating pathology specific to individuals with Type 1 Diabetes such as purposefully not taking enough insulin.
Time Frame
pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Title
Change over time in Diabetes-Specific Distress
Description
Assessed with the 28-item Type 1 Diabetes Distress Scale (DDS; Fisher et al., 2015) which measures distress related to diabetes. Each item is assessed on a scale of 1 = Not a Problem to 6 = A Very Serious Problem. High scores indicate greater distress that are related to living with Type 1 Diabetes.
Time Frame
pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Title
Change over time in Negative Affect
Description
Negative affect will be assessed with the sadness, guilt, and fear/anxiety subscales (totaling 20 items) from the Positive Affect and Negative Affect Scale-Revised (PANAS-X; Watson & Clark, 1992). Each item is scored on a scale of 1 = Not at All to 5 = Extremely. Higher scores indicate greater negative affect.
Time Frame
pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Title
Change over time in Perceived Well-Being as assessed by the World Health Organization Well-Being Index (WHO-5; deWit et al., 2007).
Description
Assessed with the 5-item World Health Organization Well-Being Index (WHO-5; deWit et al., 2007) that measures health related quality of life. Each item is scored on a scale of 0 = At no Time to 5 = All of the Time. Higher scores indicate greater well-being
Time Frame
pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
I)female-identifying II) aged 15-30 years old III) diagnosis of T1D for at least a 6-month duration per American Diabetes Association(ADA) criteria who are taking insulin IV) have visited their diabetes care provider in the past year V) body image concerns
Exclusion Criteria:
I) not female identifying II) not in age range III) does not have a diagnosis of T1D for at least 6 months per ADA criteria who are taking insulin IV) have not visited their diabetes care provider in the past year V) do not report some level of body dissatisfaction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Stice, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Korey Hood, MDPhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Eating Disorder Prevention Program for Women With T1D
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